30 November 1998 00:00 [Source: ICB Americas]By Glenn Hess
The recent agreement on a voluntary program for testing high production volume (HPV) chemicals should serve as the starting point for negotiations aimed at overhauling the Toxic Substances Control Act (TSCA), according to a senior Environmental Protection Agency official.
"It is time to begin to talk seriously about what should be done if we have the opportunity to get some legislative changes made to TSCA," says Lynn R. Goldman, EPA assistant administrator for prevention, pesticides and toxic substances.
Dr. Goldman, who spoke at an industry sponsored forum on TSCA, cited the October 9 announcement by Vice President Al Gore that an agreement had been reached by the chemical industry, environmentalists and EPA to obtain basic health and ecological effects data on all HPV chemicals made or imported into the US.
Noting that enactment of major pesticide reform legislation in 1996 came about only after many years of negotiations, she indicated that achieving significant legislative changes in the chemical control statute would probably require a similar, lengthy effort.
TSCA reauthorization talks should begin now, Dr. Goldman said, noting that there has been a "deep sense of frustration with TSCA" among many EPA staffers who consider the 1976 law outdated. However, an industry official at the same conference stated that the main reason why chemical companies should participate in the voluntary HPV testing program is to "prevent TSCA reauthorization." Jim Quance, an official with Exxon Chemical Corporation and a consultant to Chemical Manufacturers Association, said the industry would derive a number of benefits from participating in the program rather than having to comply with a TSCA test rule.
He said that the voluntary framework would allow companies to take a flexible, less-costly approach to testing, give them control over the timing of such tests and provide an opportunity to influence how data are interpreted and used in risk assessments.
Further, Mr. Quance said, voluntary testing would demonstrate the industry's commitment to its self-imposed code for product stewardship under Responsible Care.
The chemical industry has taken the position that there are no fundamental flaws with TSCA. In comments filed with the Presidential Commission on Risk Assessment and Risk Management in August 1996, Chemical Manufacturers Association said it does not believe that Congress needs to rewrite or revise the law.
"TSCA is a risk-based statute and provides EPA with all of the authority and flexibility necessary for EPA to protect human health and the environment from unreasonable risks posed by new and existing chemicals," CMA said.
But Dr. Goldman insists changes are need for reviewing new chemicals (TSCA Section V) and managing extremely hazardous substances (TSCA Section VI).
She recommends adopting a modified version of the European approach to evaluating the safety of new industrial chemicals prior to marketing, in which a "base set of health and environmental effects data" is required.
Under TSCA, US chemical manufacturers do not have to provide EPA with toxicological data or information about a chemical's basic physical characteristics. Dr. Goldman notes that more than half of pre-manufacture notifications are submitted with no toxicity data at all. The US is the only industrialized nation that does not require the submission of such data as part of its new chemical review process.
TSCA also gives EPA broad authority to control risks from toxic chemicals. Section VI of the law allows EPA to regulate any chemical that presents "an unreasonable risk of injury to health or the environment." However, the burden of proving "unreasonable risk" falls on the agency, which "is a major shortcoming of the law," according to Dr. Goldman.
"Volunteerism is great, but it only goes so far," she says. "There will be situations, and industry knows this, where people will not voluntarily come forward [to take risk reduction actions]. And for some in industry, it is less expensive to hire lawyers and fight EPA" than to voluntarily halt the use of an extremely hazardous substance.
Dr. Goldman, who plans to leave EPA in December, says she is pleased that the relationship between her agency and the chemical industry has improved in recent years. She says it was "very adversarial" during the first few years of the Clinton administration, but the agreement on the voluntary testing initiative is evidence of considerable improvement.
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